ORYZON will provide updates on corporate progress at several events from January to February By Investing.com

• 8. Sachs Annual Forum on Innovations in Neuroscience
• LifeSci Advisors’ 14th Annual Corporate Access Event
• Invest Securities BioMed Forum 2025
• MidCap events Frankfurt 2025
• Bio-neuroscience 2025

MADRID and CAMBRIDGE, Mass., Jan. 10, 2025 (GLOBE NEWSWIRE) — Oryzon Genomics, SA (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company using epigenetics to develop therapies for diseases with high unmet medical needs, announced said today that its management will report on the company’s progress at several international events in January-February.

Oryzon has been invited to participate in the 8th Sachs Annual Neuroscience Innovation Forum, which will be held on January 12 at the Marines’ Memorial Club in San Francisco (USA). The company will provide a corporate update on its CNS program at 10:55 a.m. PT (Track A – Rosenberg Room). Oryzon will also participate in a panel titled Revolutionizing Neuropsychiatric Treatments: New Approaches at 1:15 PM PST (Command Room). Click on the link for more information on the 8th Annual Sachs Innovations in Neuroscience Forum

Oryzon has been invited to participate in the 14th Annual LifeSci Advisors Corporate Access Event, which will be held at the Beacon Grand Hotel in San Francisco (USA) from January 13 to 15, where the company will hold meetings with investors and pharmaceutical companies. Click the link for more information on LifeSci Advisors’ 14th Annual Corporate Access Event

Oryzon will attend the Invest Securities BioMed Forum 2025, which will be held at Salons Hoche in Paris (France) on February 4.

Oryzon will attend Midcap Events 2025 at the Steigenberger Icon Hotel (NASDAQ: ) in Frankfurt, Germany on February 13, where Oryzon will hold one-on-one meetings with investors. Click on the link for more information on Midcap Events Frankfurt 2025

Oryzon will also attend Bio-Neuroscience 2025, which will be held at the Jakarta Hotel in Amsterdam (Netherlands) from February 25 to 27. Click on the link for more information about Bio-Neuroscience 2025

About Oryzon
Founded in 2000 in Barcelona, ​​Spain, Oryzon (ISIN code: ES0167733015) is a clinical-stage biopharmaceutical company and a European leader in epigenetics, with a strong focus on personalized medicine in CNS disorders and oncology. Oryzon’s team is made up of highly qualified experts from the pharmaceutical industry located in Barcelona, ​​Boston and San Diego. Oryzon has an advanced clinical portfolio with two LSD1 inhibitors, vafidemstat in the CNS (phase III ready) and iadademstat in oncology (phase II). The company has other assets directed against other epigenetic targets such as HDAC-6 where the clinical candidate ORY-4001 is nominated for its possible development in CMT and ALS. In addition, Oryzon has a strong platform for biomarker identification and target validation for various malignancies and neurological diseases. For more information, visit www.oryzon.com

About Iadademstat
Iadademstat (ORY-1001) is an oral small molecule that acts as a highly selective inhibitor of the epigenetic enzyme LSD1 and has a strong differentiation effect in hematologic cancers (see Maes et al., Cancer Cell 2018 Mar 12; 33(3) : 495-511 .e12.doi: 10.1016 / j.ccell.2018.02.002.). An FiM phase I/IIa clinical trial with iadademstat in patients with R/R AML showed safety and good drug tolerability and preliminary signs of antileukemic activity, including CRi (see Salamero et al, J Clin Oncol, 2020, 38(36) ): 4260-4273 doi: 10.1200/JCO.19.03250). Iadademstat showed encouraging safety and strong clinical activity in combination with azacitidine in a phase IIa trial in elderly patients with 1L AML (the ALICE trial) (see Salamero et al., ASH 2022 oral presentation & The Lancet Haematology, 2024, 11(7): e487-e498). Iadademstat is currently being evaluated in combination with gilteritinib in the phase Ib FRIDA trial in relapsed/refractory AML patients with FLT3 mutations, and in combination with azacitidine and venetoclax in 1L AML in an OHSU-led investigator-initiated study and in the trial according to the Cooperative Research and Development Agreement (CRADA) signed with the US National Cancer Institute (NCI) for further clinical development cooperation iadademstat in different types of hematological and solid cancers. In addition to hematologic cancers, LSD1 inhibition has been proposed as a valid therapeutic approach in some solid tumors such as small cell lung cancer (SCLC), neuroendocrine tumors (NET), medulloblastoma, and others. In a phase IIa trial in combination with platinum/etoposide in second-line ED-SCLC patients (CLEPSIDRA trial), preliminary activity and safety results were reported (see Navarro et al., ESMO 2018 poster). Iadademstat is in a collaborative phase II trial with Fox Chase Cancer Center (FCCC) in combination with paclitaxel in R/R neuroendocrine carcinomas, and in a randomized phase I/II trial in 1L ED-SCLC in combination with ICIs sponsored by NCI and led by Memorial Sloan Kettering Cancer Center (IND approved). Oryzon is further expanding the clinical development of iadademstat through additional investigator-initiated studies. Iadademstat has Orphan Drug Designation for SCLC in the US and for AML in the US and EU.

About Vafidemstat
Vafidemstat (ORY-2001) is an oral LSD1 inhibitor optimized for the CNS. The molecule works on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, while also being neuroprotective. In animal studies, vafidemstat not only restores memory, but reduces increased aggression in SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and increases sociability in mouse models. In addition, vafidemstat shows rapid, potent and long-lasting efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has conducted two Phase IIa clinical trials investigating aggression in patients with various psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results in both cases. Additional finalized phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with mild to moderate AD, where significant reductions in the inflammatory biomarker YKL40 were observed after 6 and 12 months of treatment, and the pilot, small trial of SATEEN in Relapse-Remitting and Secondary Progressive Multiple sclerosis, where an anti-inflammatory effect was also observed. Vafidemstat was also tested in phase II in patients with severe Covid-19 (ESCAPE) evaluating the drug’s ability to prevent ARDS, one of the most severe complications of viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Vafidemstat is currently advancing as a Phase III-ready agent in borderline personality disorder (BPD) following completion of the global, randomized, double-blind, phase IIb PORTICO trial (final data presented at ECNP-2024). After receiving the minutes of the end-of-phase II meeting with the FDA to discuss the results of PORTICO, the company announced plans to continue the phase III trial of PORTICO-2 in BPD (FDA submission planned for Q1 2025). Vafidemstat is also being investigated in a double-blind, randomized, placebo-controlled phase IIb trial in negative symptoms of schizophrenia (EVOLUTION trial, ongoing recruitment). The company is also applying a CNS precision medicine approach with vafidemstat in genetically defined subpopulations of patients with certain CNS disorders and is evaluating a clinical trial in patients with Kabuki syndrome. The company is also investigating the clinical development of vafidemstat in other neurodevelopmental syndromes.

FORWARD-LOOKING STATEMENTS
This communication contains or may contain forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements about plans, objectives and expectations regarding future operations, capital expenditures, synergies, products and services, and statements about future performance . Forward-looking statements are statements that are not historical facts and are generally identified by the words expects, predicts, believes, intends, estimates and similar expressions. Although Oryzon believes that the expectations expressed in such forward-looking statements are reasonable, investors and holders of Oryzon stock are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, implied or anticipated by the forward-looking information and statements. These risks and uncertainties include those discussed or identified in publicly available documents submitted by Oryzon to Spain’s Comisión Nacional del Mercado de Valores (CNMV). Forward-looking statements are not guarantees of future performance and have not been reviewed by Oryzon’s auditors. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they are made. Any subsequent oral or written forward-looking statements attributable to Oryzon or any of its members, directors, officers, employees or any person acting on its behalf are expressly qualified in their entirety by the foregoing cautionary statement. All forward-looking statements included herein are based on information available to Oryzon as of the date hereof. Except as required by applicable law, Oryzon undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. This press release is not an offer of securities for sale in the United States or any other jurisdiction. Oryzon’s securities may not be offered or sold in the United States without registration or an exemption from registration. Any public offering of Oryzon’s securities to be made in the United States will be made by means of a prospectus obtainable from Oryzon or the selling securityholder, as applicable, which will contain detailed information about Oryzon and management, as and financial statements.

Source: Oryzon Genomics, SA